Biotech Values

[DewDiligence]

MNTA Announces FDA Approval for First Generic Lovenox

[Conference call at 1pm ET.]

http://www.earthtimes.org/articles/press/approval-first-generic-lovenoxr,1396141.html

›Fri, 23 Jul 2010 15:25:25 GMT

CAMBRIDGE, Mass., July 23, 2010 (GLOBE NEWSWIRE) -- Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA), a biotechnology company specializing in the characterization and engineering of complex drugs, today announced that the U.S. Food and Drug Administration has granted marketing approval of the Abbreviated New Drug Application (ANDA) for enoxaparin sodium for injection filed by Sandoz. Developed under a collaboration agreement between Momenta and Sandoz, this product has been designated therapeutically equivalent to the reference-listed drug, Lovenox®, which is marketed by Sanofi-Aventis.

"The approval of M-Enoxaparin marks a key milestone for Momenta, and we are extremely pleased," commented Craig Wheeler, President and CEO. "This is the first product based on Momenta's technology platform to be approved, and demonstrates our ability to characterize and develop a complex mixture drug like Lovenox."

The Company is aware that other ANDAs for enoxaparin sodium injection have been filed. These other applicants may receive approval at a later date.

Conference Call Information

Management will host a conference call on July 23, 2010 at 1:00 pm ET. Call details to follow separately.‹